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European Project on Nutrition in Elderly People (NU-AGE)

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ClinicalTrials.gov Identifier: NCT01754012
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : February 18, 2016
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Claudio Franceschi, University of Bologna

Study Description
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Brief Summary:
NU-AGE is a large multidisciplinary consortium (31 partners, from 17 EU countries) involving nutritionists, bio-gerontologists, immunologists and molecular biologists from the most prestigious institutions in Europe, 5 large food industries, 8 traditional food companies and 1 biotech SME, SPES GEIE and CIAA, covering the SME Food Industrial Associations of 13 European countries and the European Confederation the food and drink industry. NU-AGE aims are: 1. to counteract the physical/cognitive decline occurring in the elderly as a consequence of the progressive alteration of different organs/systems (immune and cardiovascular systems, bone, brain, muscle and intestine) by one year elderly-tailored whole diet intervention on 1250 healthy elderly men and women aged 65-79 years (half diet, half control) from 5 different EU regions; 2. to assess the effect of the newly designed food pyramid specific for 65+ EU citizens on the different organs/systems using a large set of biomarkers related to nutrition and aging, with particular attention to the low grade, chronic, systemic inflammatory status named inflammageing, a major risk factor for common age-related diseases; 3. to perform in a subgroup of 120 subjects in depth studies and high throughput "omics" to identify cellular/molecular targets/mechanisms responsible for whole diet effect; 4. to perform genetic and epigenetic studies to assess the role of individual variability on the response to diet; 5. to adopt an integrative comprehensive approach (systems biology) to analyze the whole set of data. The results of dietary intervention will be used to develop elderly-tailored prototypes of functional foods and to improve traditional foods. The research activity will be accompanied and followed by a strong activity of dissemination and industrial exploitation to support EU strategies on nutritional recommendations, thus contributing to the implementation of legislation related to nutritional and health claims for elderly in Europe.

Condition or disease Intervention/treatment Phase
Aging Dietary Supplement: Dietary Intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: New Dietary Strategies Addressing the Specific Needs of Elderly Population for an Healthy Aging in Europe
Study Start Date : April 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dietary Intervention
This group will follow for a year the NU-AGE whole diet approach elderly-specific and will be supplemented with 10micrograms per day of Vitamin D (cholecalciferol) from MCOHealth.
 Dietary Supplement: Dietary Intervention
nutrient-rich diet and 10micrograms per day of Vitamin D (cholecalciferol) supplement from MCOHealth
Other Names:
  • NU-AGE diet
  • NU-AGE whole diet approach
No Intervention: Control Group
This group will follow the habitual diet.


Outcome Measures
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Primary Outcome Measures :
  1. Inflammatory Response [ Time Frame: 1 year ]

    Reduction of inflammatory markers after one-year of NU-AGE dietary intervention in elderly.

    Measures of inflammatory status and immune health will be evaluated on plasma: C-reactive protein (hsCRP) IL-1Beta, IL-12, INF gamma, IL-6, sIL-6R, IL-1RA, TNFalpha, IL-17, IL-8, IL-10, TGF-beta1, positivity for HCMV.



Secondary Outcome Measures :
  1. Cognitive Status [ Time Frame: 1 year ]

    The following standardized questionnaires will be administered to volunteers pre and post dietary intervention to evaluate cognitive function:

    1. CERAD Neuropsychological Assessment Battery
    2. Domain Specific Tests (GDS, Babcock story Recall, Trail Making Test)

  2. Cardiovascular Health Status [ Time Frame: 1 year ]
    Evaluation of blood pressure and measure of lipid profile (triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol) pre and post dietary intervention on plasma.

  3. Insulin sensitivity [ Time Frame: 1 year ]
    Glucose, insulin and Hba1C will be measured on plasma pre and post dietary intervention

  4. Liver Function Status [ Time Frame: 1 year ]
    ASAT, ALAT, GGT and alkaline phosphatase parameters will be measured on plasma samples pre and post dietary intervention.

  5. Hormonal Status [ Time Frame: 1 year ]
    Leptin and adiponectin hormones will be measured on plasma samples pre and post dietary intervention

  6. Nutritional Status [ Time Frame: 1 year ]
    The Nutritional status will be evaluated on plasma measuring vitamin B12 and folate concentrations.

  7. Digestive Health Status [ Time Frame: 1 year ]
    Questionnaire to assess bowel function, gastrointestinal disturbances and evacuation frequency will be administered to participants pre and post dietary intervention.

  8. Bone Health Status [ Time Frame: 1 year ]
    All participants, pre and post dietary intervention, will undergone DXA exam to evaluate bone mineral density, also 25-OH vitamin D, parathyroid hormone will be measured on plasma samples.

  9. Physical Functioning [ Time Frame: 1 year ]

    The following standardized questionnaires will be administered to volunteers pre and post dietary intervention to evaluate physical function:

    1. SPPB
    2. Hand grip test
    3. Gait Speed Test
    4. ADL, IADL
    5. PASE

  10. Changes on Cellular and Molecular mechanisms after diet: Immunological Status [ Time Frame: 1 year ]

    On a subgroup of 125subjects (pre and post diet), the following of additional analyses on plasma will be performed to evaluate the immunological status of participants:

    1. Expression and responsiveness of Toll-like receptors, measured as production of downstream cytokines (IFN-a, IFN-b, IFN-y, IL12p40, IL12p70, SOCS3)
    2. Expression of co-stimulatory molecules (CD1, MHC Class II, CD40, CD80, CD86, CD152, CD154, DC1/DC2)

  11. Changes on Cellular and Molecular mechanisms after diet: Epigenetic signature [ Time Frame: 1 year ]
    On a subgroup of 120 subjects (pre and post diet), the epigenetic signature will be evaluated through methylation assay on isolated PBMC.

  12. Changes on Cellular and Molecular mechanisms after diet: biochemical modifications [ Time Frame: 1 year ]
    On a subgroup of 120 subjects (pre and post diet), proteasome and immunoproteasome composition and activity will be measured on proteins from isolated PBMC.

  13. Transcriptomics [ Time Frame: 1 year ]
    On a subgroup of 120 subjects (pre and post diet) a transcriptomics analysis will be performed on mRNA from isolated PBMC by high throughput technologies "omics".

  14. Metabolomics [ Time Frame: 1 year ]
    On a subgroup of 120 subjects (pre and post diet) a the metabolic profile will be performed on urine and plasma/serum by high throughput technologies "omics".

  15. Metagenomics [ Time Frame: 1 year ]
    On a subgroup of 120 subjects (pre and post diet) the functional and compositional analysis of the microbiota will be assessed on feces by high throughput technologies "omics".


Other Outcome Measures:
  1. Habitual Diet [ Time Frame: 4 months ]
    Over the course of the 1-year intervention period assessment of habitual diet, will be conducted by repeated the 7 days nutritional diary administered in person (month 1 and 12) and 3 days nutritional diary administered at interim time points (months 4-8) by telephone.

  2. Genetic profiling [ Time Frame: Time 0 ]
    The genetic profiling of genes involved in inflammageing will be analyzed (only before diet) in order to assess genotype-phenotype and genotype-diet phenotype associations.

  3. General Health information [ Time Frame: 1 year ]
    Information will be collected at month 1 and 12 on smoking status, health status, physical activity levels, alcohol consumption and medication and supplement use, so that these parameters can be added to all statistical analysis models as confounders


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 79 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 65-79 years old.
  • Free of clinically diagnosed overt disease for at least 2 years.
  • Free-living, independent.

Exclusion Criteria:

  • <65 or > 79 years old.
  • Overt disease such as aggressive cancer or dementia.
  • Unstable organ failure or organ failure necessitating a special diet.
  • Heart failure.
  • Renal failure.
  • Respiratory failure.
  • Liver failure.
  • Type 1 diabetes mellitus.
  • Chronic use of corticosteroids.
  • Recent (previous 2 months) use of antibiotics.
  • Recent (previous 3 months) change to habitual medication (e.g statins and thyroxine) use
  • Presence of food allergy/intolerance or disease necessitating a special diet.
  • Malnutrition, as diagnosed by body mass index < 18.5 kg/m2.
  • Body weight loss of >10% BW within 6 months.
  • Presence of frailty (as assessed by the presence of at least three out of five criteria according to Fried et al., 2001: unintentional weight loss, self-reported exhaustion, weakness (grip strength), slow walking speed, and low physical activity).
  • Individual unable to give informed consent.
  • Volunteers showing previously unrecognized illness will also be excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754012


Locations
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France
Auvergne Research Center on Human Nutrition
Clermont-Ferrand, France, 63009
Italy
University of Bologna-Department of Speciality, Diagnostic and Experimental Medicine
Bologna, Italy, 40126
Netherlands
University of Wageningen-Division of Human Nutrition
Wageningen, Netherlands, 6703 HD
Poland
Warsaw University of Life Science SGGW-WULS-Department of Human Nutrition
Warsaw, Poland, 02-776
United Kingdom
Department of Nurition-University of East Anglia
Norwich, United Kingdom, NR4 7TJ
Sponsors and Collaborators
University of Bologna
European Commission
Investigators
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Principal Investigator: Claudio Franceschi, MD University of Bologna
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Claudio Franceschi, Professor, University of Bologna
ClinicalTrials.gov Identifier: NCT01754012    
Other Study ID Numbers: 266486
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: February 2016
Keywords provided by Claudio Franceschi, University of Bologna:
Nutrition
Dietary intervention
Aging
 Inflammation
Elderly
Europe